September 5, 2015
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Cutivate Lotion

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Cutivate Lotion




Cutivate Lotion Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cutivate (fluticasone propionate) Lotion is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis. It is a topical (for the skin) steroid. This medication is available in generic form. Common side effects include mild skin itching, burning, peeling, dryness, changes in color of treated skin, headache, thinning or softening of skin, skin rash or irritation around mouth, swollen hair follicles, blisters, pimples, or crusting of treated skin, or stretch marks.

The recommended dose is to apply a thin film of Cutivate Lotion to the affected skin areas once daily. Rub in gently. It is not likely other drugs you take orally or inject will have an effect on topically applied Cutivate. Tell your doctor all medications and supplements you use. During pregnancy, Cutivate should be used only if prescribed. It may be harmful to a fetus. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Cutivate (fluticasone propionate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cutivate Lotion in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when fluticasone topical is applied to the skin, side effects can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have signs of absorbing fluticasone topical through your skin, such as:

  • blurred vision, or seeing halos around lights;
  • headache, back ache, weakness, confusion, mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face;
  • muscle weakness, feeling tired; or
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Less serious side effects may include:

  • mild skin itching, burning, peeling, or dryness;
  • changes in color of treated skin;
  • thinning or softening of your skin;
  • skin rash or irritation around your mouth;
  • redness or crusting around your hair follicles;
  • blisters, pimples, or crusting of treated skin; or
  • stretch marks.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cutivate Lotion (Fluticasone Propionate Lotion)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cutivate Lotion FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • HPA Axis Suppression and Other Adverse Endocrine Effects [see WARNINGS AND PRECAUTIONS]
  • Local Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Concomitant Skin Infections [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience: Controlled Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 2 multicenter vehicle-controlled clinical trials of once-daily application of CUTIVATE® Lotion by 196 adult and 242 pediatric patients, the total incidence of adverse reactions considered drug related by investigators was approximately 4%. These were local cutaneous reactions, usually mild and self-limiting, and consisted primarily of burning/stinging (2%). All other drug-related events occurred with an incidence of less than 1%, and included were contact dermatitis, exacerbation of atopic dermatitis, folliculitis of legs, pruritus, pustules on arm, rash, and skin infection. See Table 1.

The incidence of adverse reactions between the 242 pediatric subjects (age 3 months to < 17 years) and 196 adult subjects (17 years or older) was similar (4% and 5%, respectively).

Table 1: Adverse Reactions from Controlled Clinical Trials (N=438)

Adverse Reactions CUTIVATE® Lotion
n=221
VEHICLE
n=217
Buming/Stinging skin 4 (2%) 3 (1%)
Contact Dermatitis 0 1 ( < 1%)
Exacerbation of Atopic dermatitis 0 1 ( < 1%)
Folliculitis of legs 2 ( < 1%) 0
Irritant Contact Dermatitis 0 1 ( < 1%)
Pruritus 1 ( < 1%) 1 ( < 1%)
Pustules on Arms 1 ( < 1%) 0
Rash 1 ( < 1%) 2 ( < 1%)
Skin Infection 0 3 (1%)

During the clinical trials, eczema herpeticum occurred in a 33-year old male patient treated with CUTIVATE® Lotion.

Table 2 summarizes all adverse events by body system that occurred in at least 1% of patients in either the drug or vehicle group in the phase 3 controlled clinical trials.

Table 2: Adverse Events Occurring in ≥ 1% of Patients from Either Arm from Controlled Clinical Trials (n=438)

Body System CUTIVATE® Lotion
N = 221

Vehicle Lotion
N = 217

Any Adverse Event 77 (35%) 82 (38%)
Skin
  Burning and Stinging 4 (2%) 3 (1%)
  Pruritus 3 (1%) 5 (2%)
  Rash 2 ( < 1%) 3 (1%)
  Skin Infection 0 3 (1%)
Ear, Nose, Throat
  Common Cold 9 (4%) 5 (2%)
  Ear Infection 3 (1%) 3 (1%)
  Nasal Sinus Infection 2 ( < 1%) 4 (2%)
  Rhinitis 1 ( < 1%) 3 (1%)
  Upper Respiratory Tract Infection 6 (3%) 7 (3%)
Gastrointestinal
  Normal Tooth Eruption 2 ( < 1%) 3 (1%)
  Diarrhea 3 (1%) 0
  Vomiting 3 (1%) 2 ( < 1%)
Lower Respiratory
  Cough 7 (3%) 6 (3%)
  Influenza 5 (2%) 0
  Wheeze 0 3 (1%)
Neurology
  Headache 4 (2%) 5 (2%)
Non-Site Specific
  Fever 8 (4%) 8 (4%)
  Seasonal Allergy 2 ( < 1%) 3 (1%)

Clinical Trials Experience: Pediatric Open Label Trials

In an open label HPA axis suppression trial of 44 pediatric subjects (ages ≥3 months to ≤ 6 years) CUTIVATE® Lotion was applied twice daily (rather than the indicated dosing regimen of once daily) to at least 35% of body surface area for 3 or 4 weeks. Subjects whose lesions cleared after 2 or 3 weeks of treatment continued to apply CUTIVATE® Lotion for an additional week. The overall incidence of adverse reactions was 14%. These were local, cutaneous reactions and included dry skin (7%), stinging at application site (5%), and excoriation (2%). Additionally, a 4-month-old patient treated with CUTIVATE® Lotion had marked elevations of the hepatic enzymes AST and ALT. [see Use in Specific Populations]

In another open label HPA axis suppression trial in which CUTIVATE® Lotion was also applied twice daily (rather than the indicated dosing regimen of once daily), 56 pediatric subjects (ages ≥3 months to 12 months), were enrolled [see Use in Specific Populations].

The adverse reactions included 2 cases of Herpes simplex at the application site (3.6%) and 3 cases of bacterial skin infections (5.4%).

Postmarketing Experience

The following local adverse reactions have been identified during post-approval use of CUTIVATE® Lotion: erythema, edema/swelling, and bleeding.

The following systemic adverse reactions have been identified during post-approval use of CUTIVATE® Cream and CUTIVATE® Ointment: immunosuppression/Pneumocystis jirovecii pneumonia/leukopenia/thrombocytopenia; hyperglycemia/ glycosuria; Cushing syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling).

The following local adverse reactions have also been reported with the use of topical corticosteroids, and they may occur more frequently with the use of occlusive dressings or higher potency corticosteroids. These reactions include: acneiform eruptions, hypopigmentation, perioral dermatitis, skin atrophy, striae, hypertrichosis and miliaria.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Cutivate Lotion (Fluticasone Propionate Lotion)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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